MEDICAL
PRNewswire | June 02, 2023
During this year's AAPS National biotechnology conference, Navigate BioPharma Services, Inc., a Novartis subsidiary and a leading provider of innovative biomarker solutions for drug development, announced the launch of its new multiplex digital PCR assays for comprehensive quantification of multiple chimeric antigen receptor (CAR) T cells, a type of cancer immunotherapy that involves genetically modifying T cells to recognize and destroy certain cancers. These assays are based on the Qiagen QIAcuity digital PCR System, which offers a powerful yet easy-to-use digital PCR experience through its unique nanoplate system.
The new multiplex digital PCR assay enables simultaneous measurement of the number, function and persistence of CAR-T cells in clinical blood and bone marrow samples, without the need for a standard curve. It can detect as low as 0.01% of CAR-T cells among normal T cells, with a turnaround time of less than two hours. These assays can measure up to five different CAR-T cell markers in a single reaction, using specific probes for different CAR targets, to quantitate multiple CAR-domains, or combinations of commonly used therapeutic targets for CAR-T therapies. The assay can help clinicians monitor response or safety events during clinical trials to enable the development of new therapies.
"CAR-T therapy is a promising and innovative approach to treat cancer, but it requires accurate and reliable quantification of CAR-T cells for successful drug development," said Dr. Nathan Riccitelli, Associate Director of Innovative Technologies at Navigate BioPharma Services, Inc. "Our new proprietary multiplex digital PCR assay provides a comprehensive and robust solution for measuring CAR-T cells in clinical samples with high sensitivity, specificity and reproducibility."
Navigate BioPharma Services, Inc. has developed this assay for use in sponsors-led clinical trials. If interested, contact them about how this assay can be used in upcoming clinical trial studies.
Navigate Biopharma Services, Inc.
Navigate BioPharma Services, Inc., an independently operating subsidiary within the Novartis group of companies, is a leading provider of innovative biomarker and specialty bioanalytic solutions for clinical development. Over the past decade, Navigate BioPharma has built and developed its exclusive library of assays, methodologies, and biomarker solutions. Their extensive expertise offers unique, accurate, reliable, and cost-effective solutions for its customers and partners.
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INDUSTRIAL IMPACT, MEDICAL
Globenewswire | April 05, 2023
Absci Corporation a generative AI drug creation company, and M2GEN, an oncology bioinformatics company with the most advanced lifetime-consented clinicogenomics data to accelerate discovery research, today announced a partnership to create new cancer medicines and bring them to market at unprecedented speed. Absci’s generative AI drug creation platform will tap into M2GEN’s clinical and molecular data set, ORIEN AVATAR® (AVATAR), to accelerate the creation of therapeutics for a range of malignancies and patient profiles, bringing AI drug creation to the fight against cancer.
A key challenge in creating effective cancer treatments is finding specific antigens that can be targeted by immunotherapies. M2GEN’s AVATAR database represents a valuable resource for discovering such antigens. Absci will use its reverse immunology technology to first search the database for antibodies from patients with exceptional immune responses, then computationally re-assemble antigen-antibody pairs as promising starting points for drug development.
This partnership brings together AI drug creation technology and oncology bioinformatics to potentially reduce the time and cost to create better cancer treatments. Absci’s Integrated Drug Creation™ platform unites generative AI and wet-lab capabilities to screen billions of cells per week, allowing it to go from AI-designed antibodies to lab-validated candidates in as little as six weeks. As the nexus between patients, researchers, and the pharmaceutical industry, M2GEN is uniquely positioned and equipped with the richest clinicogenomic data set, and a lifetime patient-consented Total Cancer Care® (TCC) protocol, to accelerate drug discovery and development and transform how cancer is treated. M2GEN’s real-world data set comes from its Oncology Research Information Exchange Network® (ORIEN) partners, an alliance of 18 cancer centers across more than a dozen U.S. states.
“M2GEN and its ORIEN partners are premier leaders in the field of oncology data research and bring a wealth of unique data sets to our generative AI platform that may enable us to ultimately shave years off the drug discovery process,” said Sean McClain, CEO of Absci. “This is an important leap forward to better understand individualized protein-protein interactions on cancer cells, moving us toward delivering on the promise of personalized medicine.”
The cornerstone of ORIEN is the lifetime-consented TCC protocol, one of the first longitudinal cancer patient databases of its kind, with over 360,000 patients enrolled nationwide. TCC enables patient monitoring throughout their treatment journey, with the goal to transform how cancer is treated. M2GEN and ORIEN research-facilitated projects are monitored by a multi-institution governing body, which includes scientists and research leaders from network members, to ensure adherence to privacy protocols and best practices.
“Absci’s recent breakthrough creating de novo antibodies changed the idea of what’s possible for drug discovery,” said Jim Gabriele, CEO of M2GEN. “This was just one of the things that excited us about partnering together. Their AI-led approach to targeting biologics to make the drug discovery process more efficient and dramatically impact patients’ lives made them an ideal partner,” said Gabriele. “Together, by utilizing our real-word data, we plan to advance personalized cancer treatments in pursuit of a cure.”
This partnership maintains Absci’s momentum building one of the largest repositories of patient data in the industry to train its generative AI platform for protein drug creation. The company recently partnered with St. John’s Cancer Institute to train on their datasets to discover medicines faster.
About Absci
Absci is a generative AI drug creation company that combines AI with scalable wet lab technologies to create better biologics for patients, faster. Our Integrated Drug Creation™ platform unlocks the potential to accelerate time to clinic and increase the probability of success by simultaneously optimizing multiple drug characteristics important to both development and therapeutic benefit. With the data to learn, the AI to create, and the wet lab to validate, Absci can screen billions of cells per week, allowing it to go from AI-designed antibodies to wet lab-validated candidates in as little as six weeks. Absci’s vision is to deliver breakthrough therapeutics at the click of a button, for everyone. Absci's headquarters is in Vancouver, WA, its AI Research Lab is in New York City, and its Innovation Center is in Zug, Switzerland.
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INDUSTRIAL IMPACT, MEDICAL
Globenewswire | March 27, 2023
Iovance Biotherapeutics, Inc. a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, announced it has completed its rolling Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for lifileucel. Lifileucel is a tumor infiltrating lymphocyte (TIL) therapy intended as a treatment for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this treatment setting.
Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C-144-01 clinical trial and the FDA review team for their commitment and support, as well as our internal team for their tremendous effort in completing the first BLA submission for Iovance. Our preparations for commercialization remain on track to support a launch later this year. We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma patients with limited options.”
The BLA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. Following a successful pre-BLA meeting with the FDA, Iovance is pursuing accelerated approval in this indication. Iovance also reached agreement with the FDA regarding the registrational trial design for the Phase 3 TILVANCE-301 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma. TILVANCE-301 is intended to support full approval of lifileucel in post-anti-PD-1 advanced melanoma and is also designed to support registration for lifileucel in combination with pembrolizumab as therapy for advanced melanoma in the frontline setting. Startup activities for TILVANCE-301 are ongoing and the trial is expected to be well underway at the time of potential accelerated approval for lifileucel in advanced post-anti-PD-1 melanoma.
Marc Hurlbert, Ph.D., CEO of the Melanoma Research Alliance (MRA), said, “MRA congratulates Iovance for completing the BLA submission and moving closer toward making TIL therapy an option for people with advanced melanoma who have progressed following prior treatments. We hope for an FDA approval as quickly as possible for patients with significant unmet need who have no approved treatment options.”
Following receipt of the complete rolling BLA submission for lifileucel, the FDA has 60 days to determine the acceptability of the BLA for review. The rolling BLA allowed Iovance to submit portions of the BLA to the FDA on an ongoing basis, enabling the FDA to begin review as early as possible as documents were received. The rolling BLA submission and eligibility for priority review are benefits available under the FDA’s guidance on expedited programs for serious conditions, which allow for an expedited six-month review from the time of BLA acceptance. In addition, the FDA previously granted a regenerative medicine advanced therapy (RMAT) designation for lifileucel in advanced melanoma.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Our lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer.
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